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WO2018195617A1 - Système de collecte, d'examen et de lecture d'échantillons biologiques pour tests biochimiques rapides et gestion de données - Google Patents

Système de collecte, d'examen et de lecture d'échantillons biologiques pour tests biochimiques rapides et gestion de données Download PDF

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Publication number
WO2018195617A1
WO2018195617A1 PCT/BR2018/050101 BR2018050101W WO2018195617A1 WO 2018195617 A1 WO2018195617 A1 WO 2018195617A1 BR 2018050101 W BR2018050101 W BR 2018050101W WO 2018195617 A1 WO2018195617 A1 WO 2018195617A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
hardware
local remote
data
reader
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/BR2018/050101
Other languages
English (en)
Portuguese (pt)
Other versions
WO2018195617A4 (fr
Inventor
Marcus Vinicius Mazega FIGUEREDO
Sergio Renato ROGAL JUNIOR
Marcelo Junior COSSETIN
Raquel Dos Santos CEMIN
Renan Nepomoceno PINTO
Alisson Ravaglio SANTOS
Gabriel Herman Bernardim ANDRADE
Marcelo Emanuel Melani CAMATI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hi Technologies Sa
Original Assignee
Hi Technologies Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hi Technologies Sa filed Critical Hi Technologies Sa
Priority to US16/607,819 priority Critical patent/US11169164B2/en
Publication of WO2018195617A1 publication Critical patent/WO2018195617A1/fr
Publication of WO2018195617A4 publication Critical patent/WO2018195617A4/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • G01N2035/00821—Identification of carriers, materials or components in automatic analysers nature of coded information
    • G01N2035/00841—Identification of carriers, materials or components in automatic analysers nature of coded information results of the analyses

Definitions

  • the present patent refers to the system for collecting, examining and reading biological samples in rapid biochemical tests and data management applied in health in general and in Remote Laboratory Testing (TLR) in particular for the purpose.
  • TLR Remote Laboratory Testing
  • Dedicated product that reads various types of urine, blood, saliva, mucus, stool and other biological samples, bringing advantages of ease of use and optimization of operating flows, easy user training, easy and convenient registration of new tests, modular, compact Small, portable, lightweight, ergonomic, humanized, intuitive, practical and cost effective.
  • Scanadu Scout a device capable of reading vital signs such as oximetry, temperature, pressure and pulse.
  • Scanaflow capable of performing a complete urinalysis test using only a pee stick and a camera smartphone app.
  • Bluetooth® connectivity for smartphone connection; Uses smartphone for storing, processing and displaying exam information obtained; Reading vital signs such as temperature, oximetry, respiratory rate, pulse, blood pressure and stress levels; SP02, infrared thermometer and ECG sensors; Application with exam history, trends and guide for exams; User registration.; Twelve reagents including glucose, leukocytes, nitrite, blood in the urine, bilirubin, urobilogen, microalbumin, creatinine, ketone, specific gravity and their pH levels; and Smartphone application that reads the pee stick, stores and displays the information.
  • Cube Header Diagnostic System a test reading system capable of assessing and quantifying lateral flow immunochromatographic examination results based on color change or banding.
  • Accu-Chek is a device for measuring and controlling blood glucose levels.
  • Features Ability to read blood glucose reactive strips; Memory capable of storing up to 1000 daily records; Programmable event, alarm clock and date reminders; Power source: three alkaline or lithium batteries; Color display; Automatic activation that activates and deactivates the device when an exam strip is inserted; The device also turns itself off after downtime; Connectivity: Infrared (IR) data input compatible with proprietary software; Bluetooth® for insulin pump connection; Customizable parameters: Language selection, beep and vibration, bolus calculator, display backlight setting, time format selection, carbohydrate unit selection.
  • IR Infrared
  • Cobas H 232 is a rapid test system for detecting cardiac troponin T, CK-MB, myoglobin and NT-proBNP levels, the levels of these blood substances indicate whether the patient has had a myocardial infarction or other problems. heart attacks recently. Characteristics: Readability of cardiac troponin T-reactive strips, CK-MB, myoglobin, D-diameter and NT-proBNP; Memory capable of storing up to 500 test records; Power: Power supply; Sample Type: Heparinized whole venous blood; Shutdown automatic programmable between 1 and 60 minutes; e Measurement position: Operate the meter on a level and vibration-free surface when applying the sample until the required amount has been fully absorbed by the strip.
  • Urisys 1100 is a urine test strip analyzer.
  • Urine Test Strip Analyzer Wavelengths: 565nm and 610nm; Transfer Rate: 100 / h; Memory: 100 results; Interface: 2 line 24 character LCD screen; Built-in thermal printer; Supported Tests: Density, pH, Leukocytes, Nitrite, Protein, Glucose, Urobilinogen, Bilirubin, Hemoglobin.
  • System Interfaces Serial computer interface, 5-pin din socket for keyboard and barcode reader.
  • Coaguchek XS is intended to measure blood clotting time.
  • TP / INR test strip analyzer TP time amperometric detection system after activation of coagulation with recombinant human thromboplastin; Handling should be done on level surface and without vibration, keep the monitor in horizontal position; Memory: 100 test results; Interface: Infrared; Power: Four batteries; Number of tests per battery pack: Up to 300 tests or 2 years standby; Heparin sensitivity: No, up to 0.8 LU / ml for UFH and 2 antiXa for LMWH; Integrated QC: In each strip, through the same channel through which the blood passes.
  • Accutrend Plus is a test strip reader capable of performing glucose, cholesterol, triglyceride and lactate tests.
  • Features glucose, cholesterol, triglyceride and lactate strip analyzer; Measurement ranges: Glucose 20 - 600 mg / dl (1.l - 33.3 mmol / l), cholesterol 150 - 300 mg / dl (3.88 - 7.76 mmol 1), triglycerides 70 - 600mg / dl (0.80 - 6.86 mmol / 1) ), lactate 0.8 - 21.7 mmol / l (whole blood) -0.7 - 26 mmol / l (plasma); Sample material a drop of capillary blood; Memory: 100 results; Test principle: Reflectance photometry; and Power: 4 batteries.
  • Afinion AS 100 Analyzer is a multi-assay fast cartridge analyzer and can be used with various sample types. This device uses Alere Afinion Tests cartridges, which feature exam information code and sample capillary collection system. Features: Performs HbAlc, Lipid Panel, ACR and CRP exams; Color LCD display; USB connection for code reading and exam printing; POCT1-A QC compatible connectivity and operator lockout.
  • Alere Prima Analyzer is an assay device for the purpose of counting T cells in the patient's blood. This count helps in the diagnosis and monitoring of patients suffering from immunosuppression caused by the HIV virus. Features: Guarantees the counting result in just 20 minutes; Power: batteries or electric ⁇ AC; Data file incorporated into the software; Cartridges contain built-in control; Resources: Possibility of immediate clinical decision implementation; possibility of operation at the treatment site or in the laboratory; and exam data management (storing, retrieving, printing, reviewing and exporting) and no need for external control materials.
  • Diagnostic Information "The methods are described to allow a patient to conveniently test a remote biological parameter from a clinical setting (for example, at home or at work), which provides a way to reduce the stress associated with the process. devices and methods are also adaptable to provide resulting information through a communication network to a remote location and / or a third party (health care provider, health friend, etc.).
  • BIOLOGICAL IN QUICK BIOCHEMICAL TESTS AND DATA MANAGEMENT object of the present patent was developed to overcome the drawbacks, limitations and disadvantages of current systems, by means of electronic code identifier with exam data in the collection cartridge, reader with electronics, sensors and dedicated software processor that reads parameters from the exam data provided by the collection cartridge and from various types of biological samples, such as urine, blood, saliva, mucus, feces and others, and transmits data to local hardware and software that manages the data and transmits it to external hardware and software so that it can be accessed remotely by the user, bringing advantages of ease of use and optimization of operational flows, easy user training, easy and convenient, modular, compact new exam registration small, portable, lightweight, ergonomic, humanized, intuitive, more practical o and low cost.
  • the innovative point of this patent is the ability to function with any type of exam that produces results based on color variation.
  • the QR Code (IC) code identifier (IC) or similar (C) stores all the basic parameters to perform the exam, such as name, reaction time, limits, calibration points, among others.
  • IC QR Code
  • C similar
  • Cartridge reading module is controlled by remote hardware and software: allows for cost savings as it can control multiple readers at the same time.
  • the invention seeks to take advantage of commercially available tests and to facilitate their use.
  • the present product offers various types of cartridge-encapsulated rapid exams and a reader for the interpretation of the examination result with the principle of colorimetry. These features allow a lay and untrained person to be able to perform an exam of their choice with the same confidence as that performed in the laboratory.
  • FIGURE 1 showing the block diagram of interconnections between the system components of the present invention
  • FIGURE 2 showing the block diagram of the process performed including those executed by the dedicated system software of the present invention.
  • FIGURE 3 showing the block diagram of the operation of the system of the present patent.
  • the system of the present invention is comprised of cartridge assembly (C) provided with a reagent strip (TR) which produces color-based result with code identifier (IC) which stores all basic parameters for performing the process. which enables the system to perform a new exam type by only including the protocol information in the code identifier (IC) and unidirectionally linked to the reader (L); with reader (L) equipped with dedicated hardware (HDL) and dedicated software (SDL) that transmits the test result data to the local remote hardware (HRL) from reading the information and interpreting the cartridge results (C) together with sample data and cartridge code and unidirectionally linked to local remote hardware (HRL) and cartridge (C); local remote hardware (HRL), such as a tablet or mobile phone, with dedicated software (SDHL) that receives the analysis data and transmits it to the external server hardware (HES) or makes available on the screen the exam result, the data from the sample and cartridge code and patient data and bi-directionally connected to external server hardware (HES) and unilaterally to reader (L); external server

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Le présent brevet d'invention concerne un système trouvant une application dans les tests de laboratoire à distance, comprenant une cartouche (C) avec bande de réactif (TR), un lecteur (L) avec matériel dédié (HDL) et logiciel dédié (SDL), un matériel distant local (HRL) avec logiciel dédié (SDHL), un matériel externe serveur (HES) avec base de données (BD) et logiciel dédié (SDS) et un matériel externe avec interface d'accès (HEIA) avec logiciel d'interface à connexion à Internet (SICI) et logiciel dédié (SDIA) lisant des paramètres de cartouche de collecte de divers types d'échantillons biologiques et transmettant des données de sorte qu'elles puissent être accessibles à distance, offrant les avantages suivants : utilisation facile et optimisation des flux opérationnels, formation facile de l'utilisateur, enregistrement de nouveaux examens de manière simple et pratique, structure modulaire et compacte, taille réduite, portabilité, ergonomie, convivialité, intuitivité, praticité accrue et faible coût.
PCT/BR2018/050101 2017-04-25 2018-04-13 Système de collecte, d'examen et de lecture d'échantillons biologiques pour tests biochimiques rapides et gestion de données Ceased WO2018195617A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US16/607,819 US11169164B2 (en) 2017-04-25 2018-04-13 System for biological sample collection, examination and reading in quick biochemical tests and data management

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BR102017008549-0A BR102017008549A2 (pt) 2017-04-25 2017-04-25 sistema de coleta, exame e leitura de amostras biológicas em testes bioquímicos rápidos e gerenciamento de dados
BRBR1020170085490 2017-04-25

Publications (2)

Publication Number Publication Date
WO2018195617A1 true WO2018195617A1 (fr) 2018-11-01
WO2018195617A4 WO2018195617A4 (fr) 2019-01-10

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR2018/050101 Ceased WO2018195617A1 (fr) 2017-04-25 2018-04-13 Système de collecte, d'examen et de lecture d'échantillons biologiques pour tests biochimiques rapides et gestion de données

Country Status (3)

Country Link
US (1) US11169164B2 (fr)
BR (1) BR102017008549A2 (fr)
WO (1) WO2018195617A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112992298B (zh) * 2021-02-10 2022-07-12 北京声智科技有限公司 一种异常识别方法、试管关联人员确定方法及相关设备
US20230200743A1 (en) * 2021-12-23 2023-06-29 Micron Technology, Inc. Apparatus and method for differentiating between symptoms of heart attack and gerd

Citations (3)

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Publication number Priority date Publication date Assignee Title
US6295506B1 (en) * 1997-10-27 2001-09-25 Nokia Mobile Phones Limited Measurement apparatus
US20130189794A1 (en) * 2011-12-23 2013-07-25 Abbott Point Of Care Inc. Optical Assay Device with Pneumatic Sample Actuation
US20160025639A1 (en) * 2014-07-24 2016-01-28 Ortho-Clinical Diagnostics, Inc. Point of care analytical processing system

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US3633922A (en) 1968-11-11 1972-01-11 Pioneer Electronic Corp Interlocking mechanism for holding a tape cartridge in inserted position
US5899855A (en) * 1992-11-17 1999-05-04 Health Hero Network, Inc. Modular microprocessor-based health monitoring system
US5307263A (en) * 1992-11-17 1994-04-26 Raya Systems, Inc. Modular microprocessor-based health monitoring system
US6168563B1 (en) * 1992-11-17 2001-01-02 Health Hero Network, Inc. Remote health monitoring and maintenance system
JP2001319212A (ja) 2000-03-02 2001-11-16 Toshiba Corp メモリカード及びカードソケット
US6494830B1 (en) * 2000-06-22 2002-12-17 Guidance Interactive Technologies, Inc. Handheld controller for monitoring/using medical parameters
CA2421010A1 (fr) 2001-08-09 2003-02-27 Abb K.K. Machine a enduire a cartouche
WO2014025415A2 (fr) 2012-08-08 2014-02-13 Scanadu Incorporated Procédé et appareil pour effectuer et quantifier des changements de couleur induits par des concentrations spécifiques d'analytes biologiques dans un environnement automatiquement étalonné
DE102013101888B4 (de) 2013-02-26 2015-05-28 opTricon Entwicklungsgesellschaft für Optische Technologien mbH Vorrichtung zur optischen Analyse eines Teststreifens
US20140378781A1 (en) 2013-06-25 2014-12-25 Qardio, Inc. Methods and systems for acquiring diagnostic information

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6295506B1 (en) * 1997-10-27 2001-09-25 Nokia Mobile Phones Limited Measurement apparatus
US20130189794A1 (en) * 2011-12-23 2013-07-25 Abbott Point Of Care Inc. Optical Assay Device with Pneumatic Sample Actuation
US20160025639A1 (en) * 2014-07-24 2016-01-28 Ortho-Clinical Diagnostics, Inc. Point of care analytical processing system

Also Published As

Publication number Publication date
US11169164B2 (en) 2021-11-09
WO2018195617A4 (fr) 2019-01-10
BR102017008549A2 (pt) 2018-11-21
US20200182895A1 (en) 2020-06-11

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